A diverse pipeline of innovative topical skin medications, based on proprietary microencapsulation technology

EPSOLAY®

Papulopustular Rosacea Subtype II

NDA Submission Q2 2020

TWYNEO®

Acne Vulgaris

NDA Submission 2H 2020

SGT-210

Palmoplantar Keratoderma

Results in 1H/2021

Tapinarof

Psoriasis & Other Dermatological Indications

Formulation

Roflumilast

Psoriasis & Other Dermatological Indications

Formulation

Novel Drug Delivery Technology

EPSOLAY®

EPSOLAY®

Epsolay® is an investigational topical cream containing encapsulated benzoyl peroxide, 5%, for the treatment of papulopustular rosacea. Epsolay utilizes a patented technology process to encapsulate benzoyl peroxide within silica microcapsules to create a barrier between the medication and the skin. The slow migration of medication from the microcapsules delivers treatment doses onto the skin, while the barrier reduces the ability of benzoyl peroxide to induce the strong oxidation process that can result in significant skin irritation, such as erythema, burning and stinging. Silica is chemically inert, photochemically and physically stable, and is safely used in topical products. If approved, Epsolay has the potential to be the first FDA-approved single-active benzoyl peroxide prescription drug product.

PHASE III DATA

Not an actual patient – actor portrayal

TWYNEO®

TWYNEO®

Twyneo® is an investigational, antibiotic-free, fixed-dose combination of encapsulated benzoyl peroxide, 3%, and encapsulated tretinoin, 0.1%, cream for the treatment of acne vulgaris. If approved, it will be the first acne treatment that contains a fixed-dose combination of benzoyl peroxide and tretinoin, which are separately encapsulated in silica using Sol-Gel proprietary microencapsulation technology. Tretinoin and benzoyl peroxide are widely believed to be highly effective as a combination treatment for acne; however, benzoyl peroxide causes degradation of the tretinoin molecule, thereby reducing its effectiveness. The silica microcapsule protects tretinoin from oxidative decomposition by benzoyl peroxide, thereby enhancing the stability of the active drug ingredients. The silica shell also allows for an extended drug delivery time and creates a barrier between the drug substances and the skin, which may reduce the irritation typically associated with topical application of benzoyl peroxide and tretinoin on acne-affected skin.

PHASE III DATA

Not an actual patient – actor portrayal

SGT-210

SGT-210 is a novel, topical epidermal growth factor receptor inhibitor which is in development for the treatment of palmoplantar keratoderma, or PPK, a group of skin conditions characterized by thickening of the skin on the hands and soles of the feet, and basal cell carcinoma and squamous cell carcinoma, collectively referred to as non-melanoma skin cancer. SGT-210 is designed to be used alone or in combination for the treatment of hyperproliferation and hyperkeratinization disorders, including PPK.

Tapinarof and roflumilast potentially for psoriasis and other dermatological indications

We also intend to develop tapinarof, an AhRagonist, and roflumilast, a PDE4 inhibitor, each as a potential treatment of psoriasis and other dermatological indications.